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Comparative Effectiveness of Extended-Release Naltrexone versus Buprenorphine-Naloxone for Opioid Relapse Prevention (X:BOT): A Multicenter, Open-Label, Randomized Controlled Trial.

Poster presented at the College on Problems of Drug Dependence (CPDD) annual meeting, Montreal, Canada, June 17-22, 2018.

Patricia Novo, MPA, MPH (New York University School of Medicine, GNY Node), Joshua D. Lee, MD, MSc (New York University School of Medicine, GNY Node), Edward V. Nunes, MD (Columbia University, GNY Node), Ken Bachrach, PhD (Tarzana Treatment Centers, WS Node), Genie L. Bailey, MD (Stanley Street Treatment and Resources, NEC Node), Snehal Bhatt, MD (University of New Mexico School of Medicine, SW Node), Sarah Farkas, MA (NYU School of Medicine, GNY Node), Marc J. Fishman, MD (Maryland Treatment Centers, MA Node), Phoebe Gauthier, MA (NYU School of Medicine, GNY Node), Candace C. Hodgkins, PhD (Gateway Community Services, FNA Node), Jacquie King, MS (Emmes Corporation, CTN Data & Statistics Center), David S. Liu, MD (NIDA Center for the Clinical Trials Network), Abigail G. Matthews, PhD (Emmes Corporation, CTN Data & Statistics Center), Jeanine May, PhD (Emmes Corporation, CTN Data & Statistics Center), K. Michelle Peavy, PhD (Evergreen Treatment Services, PN Node), Stephen Ross, MD (NYU School of Medicine, GNY Node), Dagmar Salazar, MS (Emmes Corporation, CTN Clinical Coordinating Center), Dikla Shmueli-Blumberg, PhD (Emmes Corporation, CTN Clinical Coordinating Center), Don Stablein, PhD (Emmes Corporation), Geetha A. Subramaniam, MD (NIDA Center for the Clinical Trials Network), John Rotrosen, MD (NYU School of Medicine, GNY Node).

Extended-release naltrexone (XR-NTX), an opioid antagonist, and buprenorphine-naloxone (BUP-NX), a partial opioid agonist, are pharmacologically and conceptually distinct opioid relapse prevention interventions. This study aimed to estimate the difference in opioid relapse-free survival between XR-NTX and BUP-NX. This NIDA Clinical Trials Network protocol, CTN-0051, was initiated at 8 community-based inpatient programs, and followed participants as outpatients for 24 weeks. The primary outcome was opioid relapse-free survival (where relapse was defined as 4 consecutive weeks of non-study opioid use by urine toxicology or self-report, or 7 consecutive days by self-report).

Results found that, as expected, XR-NTX had a substantial induction hurdle -- fewer initiated XR-NTX (72%) than BUP-NX (94%). Among the intention-to-treat (ITT) population (n=570), 24-week relapse events were greater for XR-NTX (65%) than for BUP-NX (57%). Most of this difference is accounted for by early relapse in nearly all (89%) XR-NTX induction failures. Among participants successfully inducted (n=474), 24-week relapse events were similar across arms. Opioid-negative urines and opioid-abstinent days favored BUP-NX among the ITT population, but were similar across arms among the per-protocol population. Opioid craving was initially less with XR-NTX than with BUP-NX, converging by week 24. Except for XR-NTX injection site reactions, treatment-emergent adverse events did not differ between treatment groups. Five fatal overdoses occurred (2 in the XR-NTX group, 3 in the BUP-NX group).

Conclusions: In these settings, it was more difficult for participants to initiate XR-NTX, and nearly all of those who failed induction quickly relapsed. Better overall opioid outcomes for the BUP-NX group in the intention-to-treat population were directly related to differential induction failure. No differences were found between the two groups for adverse events, serious adverse events, overdoses, and fatal overdoses. Future work should focus on facilitating induction to XR-NTX and on improving treatment retention on both medications. (Poster, PDF, English, 2018)

Keywords: Buprenorphine/Naloxone | Naltrexone | Opioid dependence | Overdose | Pharmacological therapy | College on Problems of Drug Dependence (CPDD) annual meeting, 2018

Document No: 1325.

Submitted by Patricia Novo, GNY Node, 7/30/2018.

AUTHORS SEARCH LINK
Bachrach, Ken mail
Bailey, Genie L.
Bhatt, Snehal
Farkas, Sarah mail
Fishman, Marc J. mail
Gauthier, Phoebe search mail
Hodgkins, Candace C. mail
King, Jacquie mail
Lee, Joshua D. search mail
Lindblad, Robert search mail
Liu, David S. mail
Matthews, Abigail G. mail
May, Jeanine mail
Novo, Patricia mail
Nunes, Edward V. mail
Peavy, K. Michelle mail
Ross, Stephen mail
Rotrosen, John
Salazar, Dagmar mail
Shmueli-Blumberg, Dikla mail
Stablein, Don
Subramaniam, Geetha A. mail
PROTOCOLS
NIDA-CTN-0051 www


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